Givlaari

Land: Europäische Union

Sprache: Englisch

Quelle: EMA (European Medicines Agency)

Wirkstoff:

Givosiran

Verfügbar ab:

Alnylam Netherlands B.V.

ATC-Code:

A16AX16

INN (Internationale Bezeichnung):

givosiran

Therapiegruppe:

Various alimentary tract and metabolism products

Therapiebereich:

Porphyrias, Hepatic

Anwendungsgebiete:

Treatment of acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.

Produktbesonderheiten:

Revision: 5

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2020-03-02

Gebrauchsinformation

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
GIVLAARI 189 MG/ML SOLUTION FOR INJECTION
givosiran
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Givlaari is and what it is used for
2.
What you need to know before you are given Givlaari
3.
How Givlaari is given
4.
Possible side effects
5.
How to store Givlaari
6.
Contents of the pack and other information
1.
WHAT GIVLAARI IS AND WHAT IT IS USED FOR
WHAT GIVLAARI IS
Givlaari contains the active substance ‘givosiran’.
WHAT GIVLAARI IS USED FOR
Givlaari is used to treat acute hepatic porphyria in adults and
adolescents aged 12 years and older.
WHAT ACUTE HEPATIC PORPHYRIA IS
Acute hepatic porphyria is a rare illness that runs in families. It is
caused by a defect in one of the
proteins that make a molecule called haem in the liver. Because there
is a problem in one of the
proteins required to make haem, there is a build-up of some of the
substances that are used to produce
haem, namely aminolevulinic acid (ALA) and porphobilinogen (PBG).
Having too much ALA and
PBG can injure nerves and cause serious attacks of pain, nausea,
muscle weakness and changes in
mental functioning. Some people with acute hepatic porphyria may also
have symptoms, such as pain
and nausea, in between attacks. Longer-term complications that can be
seen in people with acute
hepatic porphyria include high blood pressure, chronic kidney disease
and liver disease.
HOW GIVLAARI WORKS
Thi

Fachinformation

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Givlaari 189 mg/mL solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains givosiran sodium equivalent to 189 mg
givosiran.
Each vial contains 189 mg givosiran.
Excipients with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to yellow solution (pH of approximately 7.0;
osmolality: 275 – 295 mOsm/kg).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Givlaari is indicated for the treatment of acute hepatic porphyria
(AHP) in adults and adolescents aged
12 years and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated under the supervision of a healthcare
professional experienced in the
management of porphyria.
Posology
The recommended dose of Givlaari is 2.5 mg/kg once monthly,
administered via subcutaneous
injection. Dosing is based on actual body weight.
The patient dose (in mg) and volume (in mL) should be calculated as
follows:
Patient body weight (kg) × dose (2.5 mg/kg) = total amount (mg) of
medicinal product to be
administered.
Total amount (mg) divided by vial concentration (189 mg/mL) = total
volume of medicinal product
(mL) to be injected.
_Missed dose _
If a dose is missed, treatment should be administered as soon as
possible. Dosing should be resumed at
monthly intervals following administration of the missed dose.
3
_Dose modification for adverse reactions _
In patients with clinically relevant transaminase elevations, who have
dose interruption and subsequent
improvement in transaminase levels, a dose resumption at 1.25 mg/kg
once monthly could be
considered (see sections 4.4 and 4.8).
Special populations
_Elderly _
No dose